RECRUITING

Hyperbaric Oxygen Therapy for Optic Neuropathies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.

Official Title

A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy

Quick Facts

Study Start:2022-11-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06128720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted): * Participant must be at least 18. * Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). * Participant's with clinical evidence of optic neuropathy. * Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.	* Participant is unable to comply with study procedures or follow-up visits. * Participant has evidence of corneal opacification or lack of optical clarity. * Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration. * Participant is pregnant or lactating. * Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. * Children and comatose patients. * Participant abusing drugs or alcohol. * Prior treatment with hyperbaric oxygen within the last 6 months. * Participant with claustrophobia or that cannot decompress properly.

Inclusion Criteria

Exclusion Criteria

* Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
* Participant must be at least 18.
* Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
* Participant's with clinical evidence of optic neuropathy.
* Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

* Participant is unable to comply with study procedures or follow-up visits.
* Participant has evidence of corneal opacification or lack of optical clarity.
* Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
* Participant is pregnant or lactating.
* Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
* Children and comatose patients.
* Participant abusing drugs or alcohol.
* Prior treatment with hyperbaric oxygen within the last 6 months.
* Participant with claustrophobia or that cannot decompress properly.

Contacts and Locations

Study Contact

Zac Wennberg Smith

CONTACT

6504975942

zacwenn@stanford.edu

Principal Investigator

Jeffrey L Goldberg, MD PhD

STUDY_CHAIR

Stanford University

Study Locations (Sites)

Byers Eye Institute

Palo Alto, California, 94303

United States

Collaborators and Investigators

Sponsor: Stanford University

Jeffrey L Goldberg, MD PhD, STUDY_CHAIR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Optic Neuropathy
Glaucoma